MODIFIED ACUMEN SHEATH, MODEL TTWO767

MODIFIED ACUMEN SHEATH, MODEL TTWO767 is an FDA 510(k)-cleared medical device (K050015) manufactured by Acumen Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2005. Regulation: 8.